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Sparsentan Clinical Trials 
in Focal Segmental 
Glomerulosclerosis (FSGS)

Sparsentan clinical trials in FSGS

Sparsentan is a Dual Endothelin Angiotensin Receptor Antagonist (DEARA) indicated to reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome1

Nephrotic syndrome includes the presence of three concurrent criteria: proteinuria greater than 3.5 g/24h (adults) or UPCR >2.0 g/g (pediatric patients <18 years of age), serum albumin <3.0 g/dL, and edema1

Read full prescribing information, including boxed warning, here

DUPLEX

Study design: DUPLEX is a large, global, randomized, multicenter, double-blind, active-controlled, Phase 3 study of sparsentan vs. maximum-labeled dose irbesartan in pediatric and adult patients with FSGS2

Objective: To evaluate safety, efficacy, and potential long-term nephroprotective effects of sparsentan compared to irbesartan in patients with biopsy-proven FSGS or genetic mutation known to cause FSGS2

Sparsentan versus Irbesartan in Focal Segmental Glomerulosclerosis
FSGS

Rheault MN et al. NEJM. 2023

DUPLEX: Two-Year Safety and Efficacy Results

Read summary
Patients in DUPLEX Achieved Partial or Complete Remission of Proteinuria Earlier and More Often With Sparsentan vs Irbesartan: Implications for Slowing Progression to Kidney Failure in Focal Segmental Glomerulosclerosis (FSGS)
FSGS

Tumlin J et al. Poster presented at: 
NKF Spring Clinical Meetings 2025

DUPLEX: Post Hoc Analysis of Partial or Complete Remission of Proteinuria

Read summary
Patients With Focal Segmental Glomerulosclerosis (FSGS) Achieved Low Proteinuria Targets Earlier and More Often With Sparsentan (SPAR) vs Irbesartan (IRB) in DUPLEX
FSGS

Tesar V et al. Presentation at: 
ERA 2025

DUPLEX: Post Hoc Analysis of Various Low Proteinuria Thresholds

Read summary
Patients With Focal Segmental Glomerulosclerosis (FSGS) Reach Proteinuria <0.7 g/g More Often With Sparsentan vs Irbesartan in DUPLEX: Implications for Kidney Failure Risk
FSGS

Radhakrishnan J et al. Poster presented at:
ASN 2025

DUPLEX: Post Hoc Analysis of Low Proteinuria Threshold of UPCR <0.7 g/g

Read summary
Sparsentan vs. Irbesartan in Pediatric Patients with Focal Segmental Glomerulosclerosis (FSGS) in the Phase 3 DUPLEX Trial
FSGS

Rheault MN et al. Poster presented at: 
ASN 2025

DUPLEX: Pediatric Subgroup Analysis

Read summary
Antiproteinuric Effect of Sparsentan in Patients with Genetic-Associated FSGS Enrolled in the DUPLEX Trial
FSGS

Yee J et al. CJASN. 2025

DUPLEX: Post Hoc Analysis of Patients with Genetic FSGS

Read summary

DUET

Study design: DUET is a randomized, active-controlled, dose-escalation Phase 2 study of sparsentan vs. irbesartan in pediatric and adult patients with FSGS3

Objective: To evaluate safety and efficacy of sparsentan compared to irbesartan in patients with biopsy-proven FSGS or genetic mutation known to cause FSGS3

DUET: A Phase 2 Study Evaluating the Efficacy and Safety of Sparsentan in Patients with FSGS
FSGS

Trachtman H et al. JASN. 2018

DUET: Dose Escalation Safety and Efficacy Findings

Read summary
Implications of Complete Proteinuria Remission at Any Time in Focal Segmental Glomerulosclerosis: Sparsentan DUET Trial
FSGS

Trachtman H et al. Kidney Int Rep. 2023

DUET: Post hoc Analysis 
of Complete Remission 
of Proteinuria

Read summary
Sparsentan for Focal Segmental Glomerulosclerosis in the DUET Open-Label Extension: Long-term Efficacy and Safety
FSGS

Campbell KN et al. Kidney Medicine. 2024

DUET: Open-Label Extension Safety and Efficacy Findings

Read summary
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Footnotes

DEARA, Dual Endothelin Angiotensin Receptor Antagonist; FDA, Food and Drug Administration; FSGS, focal segmental glomerulosclerosis; UPCR, urine protein-to-creatine ratio.

  1. FILSPARI® (sparsentan) Prescribing Information. San Diego, CA: Travere Therapeutics, Inc.
  2. Rheault MN et al. NEJM. 2023;389:2436-2445.
  3. Trachtman H et al. JASN. 2018;29(11):2475-2754.

MA-SP-26-0072 | May 2026